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Table 2 ISAR patient inclusion and exclusion criteria

From: International severe asthma registry (ISAR): protocol for a global registry

Inclusion Exclusion
Adult (≥18 years old) patients with severe asthma Lack of informed consent for participation
Undergoing GINA Step 5 treatmenta [19] or
Uncontrolled on GINA Step 4 treatment [19]
Uncontrolled defined as at least one of the following (per ATS/ERS guidelines [5]):
Poor symptom control: ACQ consistently > 1.5, ACT < 20 (or ‘not well controlled’) [19]
Airflow limitation: Pre-bronchodilator FEV1 < 80% predicted, with reduced FEV1/FVC (defined as less than the lower limit of normal)
Serious exacerbations: ≥1 hospitalisation, ICU stay or mechanical ventilation in the previous year
Frequent severe exacerbations: ≥2 bursts of systemic corticosteroids with each course > 3 days in the previous year
  1. aAsthma controlled on high-dose ICS/LABA treatment was not part of the current inclusion for ISAR as this treatment approach is not yet adopted by clinicians
  2. ACQ Asthma Control Questionnaire, ACT Asthma Control Test, ATS American Thoracic Society, ERS European Respiratory Society, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, GINA Global Initiative for Asthma, ICS inhaled corticosteroids; ICU intensive care unit, ISAR International Severe Asthma Registry, LABA long-acting β2-agonist